Clinical trials in BioPharma


Eric Steffe

A recent study revealed that biotechnology companies or universities discovered 42 percent of all innovative drugs approved by the US Food and Drug Administration (FDA) between 1998 and 2007.

Biotechnology companies, however, are sometimes unprepared for the intellectual property considerations that arise as a promising drug (either their own or one licensed from a university) progresses through clinical trials. Eric Steffe explains.

As companies that have at least one approved product know, numerous issues emerge that go far beyond procuring patent protection for the product and the company’s platform technology. These issues include seeking patent protection for downstream discoveries, the renewed importance of process patents, data exclusivity, inventorship disputes, and clearance of third-party patents covering commercial manufacturing methods and patient administration protocols.

Downstream discoveries and corporate publication policies

biopharma, FDA, USPTO, patent protection, biosimilars